Exploring Pain Perception Through Exercise-Induced Hypoalgesia Across Circadian Rhythms for Healthy Participants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Pressure Pain Threshold (PPT)
研究概览
简要总结
The goal of this randomized crossover clinical trial is to investigate whether exercise-induced hypoalgesia (EIH) is influenced by circadian rhythm in healthy adults aged 18-40 years.
The main questions it aims to answer are:
- Does the time of day (morning vs. evening) influence changes in pain perception following exercise?
- Do chronotype, sex, or stimulation site (bony vs. muscular) alter the magnitude of this effect?
Participants will:
- Complete questionnaires
- Undergo quantitative sensory testing
- Attend both morning and evening sessions in randomized crossover order
详细描述
Exercise-induced hypoalgesia (EIH) is a temporary reduction in pain sensitivity following physical activity. High-intensity functional training (HIFT) has been shown to produce EIH, yet the influence of circadian rhythms on this response is not well established. Circadian timing regulates physiological processes, including pain modulation, and may contribute to variability in exercise-related analgesia.
This randomized crossover trial will examine whether time of day (morning vs. evening) affects EIH in healthy adults. It will also explore the relationship between an individual's chronotype, the efficacy of EIH and the difference in magnitude between men and women, the difference in effect between bony and muscular landmarks for pressure stimulus application.
Null Hypothesis (H0) : Circadian rhythm has no significant influence on the efficacy of exercise-induced hypoalgesia (EIH), as measured by changes in pain perception before and after high intensity functional training at different times of day (morning vs. evening).
Alternative Hypothesis (H1): Circadian rhythm significantly influences the efficacy of exercise-induced hypoalgesia (EIH), with differences in pain perception before and after high intensity functional training depending on the time of day (morning vs. evening).
Each participant will complete both morning and evening sessions in randomized order, separated by ≥72 hours. Participants who completed the morning sessions will cross over to the evening sessions and vice versa. Within each session, they will perform a 12-minute supervised deep breathing control condition and a 12-minute HIFT intervention, separated by a 30-minute rest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both the participant and assessor will be masked to the individual's chronotype
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants
- •age 18 to 40 years
- •good level of English that allow the enrolled participant to provide informed consent and complete the questionnaires provided
- •being categorized as "moderate" in the International Physical Activity Questionnaire (IPAQ)
排除标准
- •inability to report pain intensity reliably
- •consumption of narcotics or tobacco products
- •regularly taking pain medications and analgesics
- •pregnant or planning to get pregnant
- •surgery within the last 12 months
- •acute or chronic pain conditions
- •uncontrolled hypertension
- •cardiovascular diseases, pulmonary diseases, neurological diseases with significant changes in somatosensory and pain perception, metabolic diseases, serious systemic diseases or conditions that restrict normal daily activities, inflammatory conditions (e.g. rheumatoid arthritis), or orthopedic injuries
- •intolerable pain during the pain perception test
- •serious psychiatric conditions (e.g., schizophrenia and bipolar disorder) or psychological disorders (e.g., depression) that may affect pain thresholds (16).
- •Severe sleep disorders and circadian rhythm disturbances
- •BMI > 30
- •serious fatigue or delayed-onset muscle soreness (9) at least 24 h after exercise sessions or a sudden change in activity for more than one week
结局指标
主要结局
Pressure Pain Threshold (PPT)
时间窗: Baseline (0 minute before intervention) and immediately post-intervention (within 2 minutes) Measured in both high intensity functional training (HIFT) and supervised deep-breathing conditions during each morning and evening session
Pressure Pain Threshold (PPT) will be measured using an algometer at standardized bony and muscular landmarks. Pressure Pain Threshold (PPT) is defined as the minimal pressure at which a participant first perceives pain. Changes in Pressure Pain Threshold (PPT) will be used to assess the magnitude of exercise-induced hypoalgesia (EIH). Unit: kg/cm²
Pressure Pain Tolerance (PPTol)
时间窗: Baseline (0 minute before intervention) and immediately post-intervention (within 2 minutes) Measured in both high intensity functional training (HIFT) and supervised deep-breathing conditions during each morning and evening session
Pressure Pain Tolerance (PPTol) will be measured using an algometer at standardized bony and muscular landmarks. Pressure Pain Tolerance (PPTol) is defined as the maximal pressure the participant is willing to tolerate. Changes in Pressure Pain Tolerance (PPTol) will be used to assess pain modulation in response to exercise across circadian phases. Unit: kg/cm²
次要结局
- Munich Chronotype Questionnaire (MCTQ)(Baseline (before any intervention session))
- Pain Catastrophizing (PCS)(Baseline (before any intervention session))
- Fear of Pain (FPQ-9)(Baseline (before any intervention session))
- Brief Version of the Pittsburgh Sleep Quality Index (B-PSQI)(Baseline (before any intervention session))
- Depression Anxiety Stress Scales (DASS-21)(Baseline (before any intervention session))
- Rate of Perceived Exertion (RPE, Borg scale)(At minute 0 (before warm-up), at minute 5 (after warm-up), every 1 minute during the high-intensity functional training (HIFT) protocol, and at minute 17 (end of session).)
- Rate of Perceived Relaxation (RPR)(At minute 0 (baseline) and at minute 12 (immediately after the supervised deep-breathing session).)
研究者
Fatema Mohamed Daoud Soliman
Principal Investigator
Medipol University